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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 May 2018
Main ID:  EUCTR2012-004007-13-DE
Date of registration: 06/06/2013
Prospective Registration: Yes
Primary sponsor: Deutsches Krebsforschungszentrum (DKFZ
Public title: This study will examine the hypothesis that Gardasil® vaccination might prevent recurrence of genital warts (condylomata acuminata) caused by human papilloma virus (HPV) type 6 or 11.
Scientific title: A randomized, placebo-controlled, phase IIIb HPV vaccination trial with Gardasil® in patients with recurrent condylomata acuminata - GaReCo
Date of first enrolment: 06/09/2013
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004007-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Germany
Contacts
Name: Representative of the Sponsor   
Address:  Im Neuenheimer Feld 242 69120 Heidelberg Germany
Telephone: 004906221424645
Email: m.pawlita@dkfz.de
Affiliation:  Deutsches Krebsforschungszentrum (DKFZ)
Name: Representative of the Sponsor   
Address:  Im Neuenheimer Feld 242 69120 Heidelberg Germany
Telephone: 004906221424645
Email: m.pawlita@dkfz.de
Affiliation:  Deutsches Krebsforschungszentrum (DKFZ)
Key inclusion & exclusion criteria
Inclusion criteria:
- External condylomata acuminata (at least one) defined as: condylomata acuminata, condylomata gigantea, keratotic genital warts, papular warty-like lesions within 6 months after removal of previously clinically diagnosed external condylomata acuminata (at least one)
- Willingness for single session ablation by scissor snip excision, curettage, electrocautery or laser surgery
- Age = 18
- Ability of patient to understand character and individual consequences of the clinical trial
- provision of written informed consent


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
- Contraindications to vaccination with Gardasil® according to the summary of product characteristics
- HIV infection or other known immune deficiency disease or current treatment with immunosuppressive drugs
- Syphilis (clinical features of first stage and second stage)
- Previous treatment with Imiquimod within the last 30 days prior to visit 1
-Previous/concomitant treatment with any other immunomodulators within the last 90 days prior to visit 1
- Previous immunization with Gardasil® or Cervarix
- Patients who are unlikely to adhere to the protocol
- Participation in other ongoing clinical trials or during their observation period
- Pregnancy (women of child bearing potential, WOCBP, will be asked before enrollment and visit 4, and a pregnancy urine test will be perofmed at visits 1-3 before study medication is applied)




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with recurrrent external condylomata acuminata located at the following genital regions: labia minora and majora, introitus vaginae, clitoris, prepuce, glans penis, coronal sulcus and frenulum, perianal skin, perineal region, inguinal- and pubes region.
MedDRA version: 20.0 Level: LLT Classification code 10010295 Term: Condylomata acuminatum System Organ Class: 100000016515
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Intervention(s)

Trade Name: Gardasil
Product Name: Gardasil
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)
Main Objective: Primary objective is to evaluate the efficacy of Gardasil® compared with placebo on the prevention of recurrence of condylomata acuminata.
The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or within 1 cm near the previously treated area and/or (2) appearance of new warts/lesions on other genital sites. All recurrences are verified by biopsy and histology.
Primary end point(s): Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or (2) appearance of new warts on other genital sites. All recurrences are verified by biopsy and histology.
Secondary Objective: To compare Gardasil® versus placebo with respect to:
•Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination
•Incidence of HPV 6/11 related external condylomata acuminata
•Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4
•HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1, visit 3 and visit 4)
•Associations between immunological and clinical outcomes
•Safety and tolerability
Timepoint(s) of evaluation of this end point: The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination.
Secondary Outcome(s)
Secondary end point(s): To compare Gardasil® versus placebo with respect to:
- Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination
- Incidence of HPV 6/11 related external condylomata acuminata
- Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4
- HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1 and visit 4)
- Associations between immunological and clinical outcomes
- Safety and tolerability
Timepoint(s) of evaluation of this end point: Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination
Secondary ID(s)
NCT-2010-1090
Source(s) of Monetary Support
Deutsches Krebsforschungszentrum (DKFZ)
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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